APPLICATION
ANDA076996
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-19
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 3MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2026-07-01Labeling · Supplement 5 · standardAP
2025-01-22Labeling · Supplement 4 · standardAP
2025-01-14Labeling · Supplement 3 · standardAP
2020-12-11Labeling · Supplement 2 · standardAP
2020-12-11Labeling · Supplement 1 · standardAP
2011-04-19OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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